Catalog Number

197-3522

Brand Name

Epimed International, Inc.

Version/Model Number

197-3522

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K030562,K030562

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

34e1ed35-5571-4dd9-8d57-e62c5f9e898d

Public Version Date

May 13, 2022

Public Version Number

1

DI Record Publish Date

May 05, 2022

Package DI Number

10818788021509

Quantity per Package

5

Contains DI Package

00818788021502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case